RA/QA News Roll: Late February 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA and the New Administration
Marty Makary will appear before the Senate Health, Education, Labor, and Pensions (HELP) Committee on March 6 for his first confirmation hearing. During this hearing, senators are expected to ask him questions about policies implemented under HHS Secretary Kennedy, particularly vaccine-related developments. They will also seek his responses to these actions.
Jeffrey Bossert Clark, an environmental lawyer, is expected to be named administrator of the Office of Information and Regulatory Affairs (OIRA). He would report to Russ Vought, director of the White House Office of Management and Budget. OIRA is a relatively obscure but influential office that reviews all regulatory actions and determines whether they advance or return for revision. The office is expected to play a key role in the Trump administration’s efforts to scale back federal regulations.
HHS Secretary Robert F. Kennedy Jr. told department staff that “nothing is going to be off limits” in his effort to reduce chronic disease, including a potential review of the nation’s childhood vaccine schedule. According to POLITICO, Kennedy outlined several areas he plans to investigate, including antidepressants, ultra-processed foods, electromagnetic radiation, and glyphosates—an herbicide found in some foods. Kennedy emphasized a commitment to “radical transparency” and pledged to crack down on industry influence and conflicts of interest within HHS. Many of the priorities he outlined align with the recently announced MAHA Commission, which he also leads, suggesting a close overlap between the commission’s work and his broader agenda at HHS.
President Trump has issued an executive order directing federal agencies to implement significant cost-cutting measures. The order mandates a review of contracts and grants, a 30-day freeze on government credit cards, stricter justification for conference travel, and the disposal of unnecessary government property and leases. These measures could threaten the FDA's regulatory science funding, particularly contract spending. The agency’s Department of Government Efficiency Team Lead will oversee the review.
FDA budget expert Steven Grossman has published an explainer detailing why some user fee-funded staff received termination notices last week. Grossman clarifies that the FDA does not classify employees as distinct “user fee employees.” Instead, user fees fund FTE positions, not specific individuals. For accounting purposes, an employee’s salary may be covered by user fees, appropriated funds, or a combination of both, depending on their activities and available funding. Additionally, many tasks funded through appropriations qualify as user fee-eligible, further complicating distinctions between funding sources for individual employees.
The FDA has extended job offers to some staff whose positions were terminated last week as part of a White House-led purge of probationary employees across the federal government. The rehired staff appear to have been granted exemptions due to the critical nature of their work or because user fees funded their positions.
The White House’s Office of Personnel Management (OPM) released a memo outlining requirements for all federal agencies, including the FDA, to develop and submit plans for reorganization and significant staff reductions. The first phase of these plans is due in the coming weeks.
The Department of Government Efficiency (DOGE) has begun its review at the FDA, focusing on scrutinizing the agency’s operations and costs. The team is reportedly examining information technology contracts as part of its assessment.
The FDA’s upcoming meeting schedule is unusually light, with only four events planned between tomorrow and the end of the year. Typically, the agency schedules dozens of events weeks or months in advance.
OPM has issued new guidance directing federal agencies to reassess and reclassify certain senior positions currently designated as “career reserved.” OPM argues that many of these positions, including more than 200 with “policy” in their titles, may not meet the technical criteria for career-reserved status. The FDA has been instructed to submit a list of all career-reserved Senior Executive Service (SES) positions to OPM by March 24, along with any requests for redesignation. Additionally, OPM has introduced new performance assessment guidelines for SES officials, capping the number of top ratings at 30% and stipulating that those receiving scores below a 3 on a 5-point scale may face removal from office.
A new executive order issued by President Donald Trump reinforces White House oversight of federal agencies, potentially undermining arguments for FDA independence. The order asserts that all agencies must submit draft regulations for White House review and consult with the administration on priorities, reinforcing the president’s executive authority. The accompanying fact sheet includes language with direct implications for the FDA, stating that OMB “will adjust so-called independent agencies’ apportionments to ensure tax dollars are spent wisely.” This suggests that OMB, under Director Russ Vought, may use impoundment authority to effectively reduce agency budgets, a move that could impact the FDA. Additionally, the fact sheet asserts that the attorney general and president “will interpret the law for the executive branch, instead of having separate agencies adopt conflicting interpretations.” This could limit the FDA’s ability to defend certain regulatory policies, potentially reshaping its role in federal rulemaking.
FDA General
Laboratory trade groups have formally presented their legal challenge against the FDA’s Laboratory Developed Test (LDT) final rule, arguing it exceeds the agency’s statutory authority. During oral arguments, attorneys for the American Clinical Laboratory Association and the Association of Molecular Pathologists contended that LDTs do not qualify as “medical devices,” a claim the FDA strongly disputes.
The court heard arguments on issues ranging from the legal definition of a medical device to the role of the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and the financial burden of implementing the rule. The presiding judge acknowledged the urgency of the case, given the rule’s first provisions take effect on May 6, and committed to issuing a ruling as soon as possible. 💉
Reuters reports that the FDA and CDC met with the World Health Organization this week to plan the composition of the agency’s influenza vaccine. This collaboration occurred despite the ongoing process of the United States withdrawing from the WHO. 💊
The CDC is investigating several hospitalizations among patients recently administered IXCHIQ, a chikungunya vaccine licensed for use in the U.S. The cases, all involving patients aged 65 and older, will be reviewed at an upcoming meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP). The findings could lead to an FDA warning or a labeling change. 💊
The FDA has published a new report outlining its drug safety activities for fiscal year 2024. Despite its title suggesting a focus on future safety priorities, the document primarily reviews major drug safety initiatives undertaken by the Center for Drug Evaluation and Research over the past year. 💊 We distilled the key takeaways here:
Patrizia Cavazzoni, former director of the FDA’s CDER, has joined Pfizer as its chief medical officer, the company announced. Cavazzoni led CDER for several years following Janet Woodcock’s departure and resigned from the FDA in January, citing a desire to spend more time with her family. 💊
The FDA may soon see a surge in applications to review manufacturing changes if the administration’s plans move forward. Bloomberg reports that Trump, in a private meeting, warned drugmakers that tariffs are coming and urged companies to shift overseas manufacturing to the U.S. Relocating manufacturing operations would be costly and complex, requiring FDA review and approval of new facilities before they could become operational. If implemented, the policy could place significant regulatory demands on the agency.
After reports that FDA staff had paused involvement in medical device standards development, the agency now appears to be reengaging in these activities. Sarah Moeller, co-chair of an AAMI working group, confirmed that “FDA is rejoining the ISO standards writing community and will be back immediately as the expert contributors we need to represent the U.S. well in the global community.” 💉
The FDA has appointed Robert F. Foster as its new chief counsel, replacing Mark Raza. Foster previously served as a judge advocate in the U.S. Army Reserve and as counsel for the Senate Health, Education, Labor, and Pensions (HELP) Committee. Unlike Raza, who had decades of experience at the FDA, Foster’s background in health policy is relatively recent, beginning in 2020.
Reuters reports that FDA staff have been instructed to avoid using certain words in external communications, including terms such as “woman,” “disabled,” and “elderly”—words that are often critical for conveying drug-related risks. Other terms on the list seen by Reuters include “underrepresented,” “underserved,” “understudied,” “sex,” “identity,” “diverse,” “promote,” “definition,” “continuum,” “ideology,” “self-assessed,” “special populations,” “elderly,” and “disabled.” However, a White House spokesperson told Reuters that many of these words do not need to be excluded.
The FDA has released its latest list of facilities that are late on payments under the Generic Drug User Fee Amendments (GDUFA) program. The list includes several notable names. Facilities in arrears may face regulatory consequences, such as delayed application reviews or compliance actions. 💊
Governing
Congressional leaders are expressing concerns that staffing cuts at the FDA could inadvertently limit the agency’s ability to use industry-paid user fees. Roll Call reports that a trigger mechanism requires the FDA to first spend a designated amount of appropriated funds before accessing user fee revenues. Lawmakers worry that the Trump administration’s workforce reductions could lower appropriations to a point where the FDA is unable to utilize these critical funds.